Malignant Tumor
Conditions
Brief summary
Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. ROBO1 is a potential target and spectacular paradigm in the diagnosis and treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK/T cell immunotherapy for malignant tumors.
Interventions
BIOLOGICALBiCAR-NK/T cells (ROBO1 CAR-NK/T cells)
The subject will be observed for any side effects during this time and all the adverse events will be recorded.
Sponsors
Asclepius Technology Company Group (Suzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18\ 75 years old, male or female 2. Life expectancy ≥ 6 months 3. ECOG score: 0-3 4. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC) 5. Advanced solid tumor was diagnosed by pathological or clinical physicians 6. Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥70 x 10\*9/L, hemoglobin≥80g/L, lymphocyte count≥15%, total bilirubin≤100 mol/L, ALT and AST less than five times of the normal level, serum creatinine less than 1.5 times of the normal level 7. Signed informed consent 8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cell transfusion
Exclusion criteria
1. Expected overall survival \< 6 months 2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months 3. Abnormal lung function: FEV (forced expiratory volume) \< 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) \< 30% prediction, blood oxygen saturation \< 90% 4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc. 5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of treatment related adverse events as assessed by CTCAE v4.03 | 1 year | Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment. |
Countries
China
Contacts
Primary ContactGuangfu Li
Backup ContactXianfeng Feng
Outcome results
None listed